ITU-T F.781.2 PDF

This Recommendation sets a basic framework for the quality assessment of artificial intelligence/machine learning (AI/ML) based decision-making assistant (DMA) software as a medical device (SaMD), which uses AI/ML technology to assist medical staff in making clinical decisions by providing suggestions on diagnostic and treatment activities. Intended uses include assisting triage, assisting evaluation, assisting detection and assisting diagnosis. The total life cycle for quality assessment includes requirements analysis, data collection, algorithm design, verification and validation, change control and other stages.